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GMP Manufacturing

Comparison of the EU GMP Guide Annex 1 Sterile Manufacturing
€ 97.00
€ 115.43
Der MwSt.-Satz richtet sich nach der Produktart, auf Print-Produkte werden 7% und auf digitale Produkte 19% berechnet. Bei Bundle-Produkten werden beide Steuersätze berücksichtigt. Vor dem endgültigen Auslösen der Bestellung wird die MwSt. bestellspezifisch angezeigt.
download (MS-Excel, Word & PDF files)
Version 2008 to Draft 2017

Edition: 1st edition 2018
1 Word, 1 Excel & 1 PDF file, in total 251 Pages
ISBN: 978-3-95807-121-6
Delivery: immediately after receipt of payment
The draft of Annex 1 of the EU GMP Guidelines keeps many responsible persons in the pharmaceutical industry busy.

Which aspects are going to change?
Am I already prepared for this?
What do I have to do now?

This download will help you answer these questions. The author Fritz Röder has compared the currently valid Annex 1 with the draft, thereby providing an excellent overview and pointing out where action is needed. A criticality index of 1-3 evaluates the various changes.

Even if the draft is not valid yet, it shows in which direction the authorities are thinking. You should be prepared for this, as a final version will soon be available.

With the download you receive an extensive MS Excel table, a MS Word file and a PDF document. You can use the download in the format that helps you best.
All files are editable.

Technical Requirements

This file is in PDF format!
Filesize: 3,13 MB

To view PDF files, you need Adobe Reader installed on your computer. If you don't, you will need to download and install it:
>>> Adobe Reader - free download

Please note the following procedure guidelines:

If you choose payment by bank transfer:

  • You will receive an advance invoice.
  • After payment is received an email with the download information will be sent.

If you choose payment by credit card:

  • Immediately after the credit card payment you will receive an email with the download information.
  • The invoice will be sent by postal mail as soon as possible.
  • Manufacturers of sterile and aseptic pharmaceuticals
  • Quality assurance
  • Production
  • External service providers
  • Consultants
Röder, Fritz

Fritz Röder is a recognised expert in the pharmaceutical industry. He has worked in a number of different positions which has allowed him develop a deep understanding of the different perspectives in a company. Mr Röder has large experience in pharmaceutical media supply, GMP environments and the processing of solid, semisolid and liquid (sterile) dosage forms. Over recent years, he has been involved in several audits and inspections. As a member of the EDQM working group “water”, the ISPE DACH expert group “water & steam” and the PDA, he has a broad network and is contributing to international standards.

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